Revised FDA Ingredient Listing Guidance

On April 13, 2018, just 25 days before the reporting deadline for large manufacturers of deemed tobacco products, the US Food and Drug Administration (FDA) published a revised Guidance for Industry: Listing of Ingredients in Tobacco Products. FDA now intends to enforce the ingredient listing requirement only with respect to those tobacco product components or parts that are made or derived from tobacco, or contain ingredients that are burned, aerosolized, or ingested during use.

The ingredient listing deadlines for the applicable components and parts of deemed finished tobacco products, however, have not changed. Large manufacturers of such products still have only until May 8, 2018, while small-scale manufacturers have until November 8, 2018.

It also remains the case that any new vapor device intended for introduction into the US market after August 8, 2016, requires Premarket Tobacco Product Application (PMTA) authorization (which requires ingredient information, along with a significant amount of additional data) before it can be marketed, and any devices on the market on August 8, 2016, have until August 8, 2022, before PMTAs are due, and can remain on the market after that date only if PMTAs for the products are accepted by FDA for review.